Exercise Effects on Atrial Fibrillation

NCT ID: NCT06607510

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-11-01

Brief Summary

Atrial fibrillation (AF) significantly affects quality of life and increases the demand for medical care of those affected. It is very important to identify triggering factors, such as oxidative stress or N-terminal pro-B-type natriuretic peptide (NT-proBNP), as well as to identify potential biomarkers through plasma analysis. At the same time, it is essential to establish adequate training and rehabilitation programs, which would result in a decrease in hospitalizations and the health care costs associated with the pathology. Current cardiac rehabilitation programs based on physical exercise, especially moderate intensity continuous training (MICT), have demonstrated effectiveness. MICT improves cardiorespiratory fitness and quality of life in patients with AF. However, high-intensity intervallic training (HIIT) has shown superior benefits in these variables.

Although HIIT traditionally has an aerobic focus, a variant called high-intensity functional training (HIFT) is suggested that incorporates muscle strengthening exercises recommended in the guidelines for AF management. This innovative modality seeks to achieve cardiovascular and neuromuscular adaptations simultaneously, with a high transfer to daily activities. Despite its potential, the effects at the functional, molecular and clinical levels in patients with AF are unknown. The purpose of the study is to determine the benefits of HIFT on molecular, functional and clinical variables in patients with AF, and to compare these benefits with those achieved with HIIT and the usual care and recommendations in current clinical practice.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental HIIT.

Subjects belonging to this group perform a 12-week supervised exercise. Treadmill walking exercise. Participants must complete four four-minute blocks at an intensity of 85-95% of peak heart rate.

Group Type: EXPERIMENTAL

Experimental HIIT

Intervention Type: OTHER

Subjects belonging to this group perform a 12-week supervised exercise (3 sessions weekly spaced at least 48 hours apart with a maximum duration of 40 minutes), followed by 12 weeks of detraining follow-up. Before starting the intervention, two familiarization sessions for assessing strength and functional capacity will be conducted. This program is designed in a standardized warm-up: joint mobility exercises and neuromuscular activation (5 minutes). Main part os the training is design in treadmill walking exercise (28 minutes). Participants must complete four four-minute blocks at an intensity of 85-95% of peak heart rate.The initial starting speed is 5 km/h and adjust the intensity with incline increments of 2%. Between sets, a prescribed active rest period lasts three minutes, during which patients walk on the treadmill at an intensity of 60-70% of peak heart. The last part of the training is a cool-down (5 minutes treadmill walking at an intensity of 50-60% of peak heart rate).

Experimental HIFT.

Subjects belonging to this group perform a 12-week supervised exercise. Four blocks of 4 minutes each of the highest number of repetitions/rounds possible (AMRAP) at an intensity of 85-95% of peak heart rate.

Group Type: EXPERIMENTAL

Experimental HIFT

Intervention Type: OTHER

Subject belonging to this group perform a 12-week supervised exercise (3 sessions weekly spaced at least 48 hours apart with a maximum duration of 40 minutes), followed by 12 weeks of detraining follow-up. Before starting the intervention, two familiarization sessions for assessing strength and functional capacity will be conducted. AMRAP will consist of a circuit of six global, functional exercises with external loads \[i) squat; ii) rowing; iii) dead weight; iv) chest press; v) step up; vi) farmer walk\]. Patients will perform 10 repetitions of each exercise and complete as many rounds as possible within the specified time. Between blocks, there will be a prescribed active rest period lasting three minutes, during which patients will walk on the treadmill at an intensity of 60-70% of peak heart rate. The last part of the training is a cool-down (5 minutes treadmill walking at an intensity of 50-60% of peak heart rate).

No intervention: Control.

These patients do not receive training sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental HIIT

Subjects belonging to this group perform a 12-week supervised exercise (3 sessions weekly spaced at least 48 hours apart with a maximum duration of 40 minutes), followed by 12 weeks of detraining follow-up. Before starting the intervention, two familiarization sessions for assessing strength and functional capacity will be conducted. This program is designed in a standardized warm-up: joint mobility exercises and neuromuscular activation (5 minutes). Main part os the training is design in treadmill walking exercise (28 minutes). Participants must complete four four-minute blocks at an intensity of 85-95% of peak heart rate.The initial starting speed is 5 km/h and adjust the intensity with incline increments of 2%. Between sets, a prescribed active rest period lasts three minutes, during which patients walk on the treadmill at an intensity of 60-70% of peak heart. The last part of the training is a cool-down (5 minutes treadmill walking at an intensity of 50-60% of peak heart rate).

Intervention Type: OTHER

Experimental HIFT

Subject belonging to this group perform a 12-week supervised exercise (3 sessions weekly spaced at least 48 hours apart with a maximum duration of 40 minutes), followed by 12 weeks of detraining follow-up. Before starting the intervention, two familiarization sessions for assessing strength and functional capacity will be conducted. AMRAP will consist of a circuit of six global, functional exercises with external loads \[i) squat; ii) rowing; iii) dead weight; iv) chest press; v) step up; vi) farmer walk\]. Patients will perform 10 repetitions of each exercise and complete as many rounds as possible within the specified time. Between blocks, there will be a prescribed active rest period lasting three minutes, during which patients will walk on the treadmill at an intensity of 60-70% of peak heart rate. The last part of the training is a cool-down (5 minutes treadmill walking at an intensity of 50-60% of peak heart rate).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Paroxysmal or persistent atrial fibrillation.
• Age between 18 and 80 years.
• Sedentary lifestyle.
• Signed informed consent.

Exclusion Criteria

• Permanent atrial fibrillation.
• Moderate to severe left ventricular dysfunction.
• Moderate to severe left valvulopathy.
• Severe pulmonary hypertension.
• Ischemic heart disease with incomplete revascularization.
• Arrhythmogenic cardiomyopathy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: collaborator

European University Miguel de Cervantes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Europea Miguel de Cervantes

Valladolid, , Spain

Countries

Spain

Central Contacts

Alejandro Santos, PhD

Role: CONTACT

asantos@uemc.es

+34983001000

Facility Contacts

Alejandro Santos, PhD

Role: primary

asantos@uemc.es

Other Identifiers

PI-DOC004-AF

Identifier Type: -

Identifier Source: org_study_id